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New treatment option for Urolithiasis
Official title Antibiotic Prophylaxis for Ureteroscopy With a Negative Pressure Suction Sheath
ClinicalTrials.gov ID: NCT07246967
What this study is testing
What is not use any prophylactic antimicrobials?
not use any prophylactic antimicrobials is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for urolithiasis.
Also referred to as without the use of any antimicrobial drugs for prophylaxis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study, as a prospective, randomized, controlled, non-inferiority, international multicenter clinical trial, aims to evaluate whether a strategy of no antimicrobial prophylaxis is non-inferior to the traditional single-dose prophylaxis regimen in patients with a low risk of infection undergoing single-use flexible ureteroscopic lithotripsy combined with a flexible negative-pressure suction sheath. It is anticipated that this will have a substantial impact on infection prevention strategies in urological surgery.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Age 18-75 years.
- Diagnosed by CT with renal and/or upper ureteral stones, with the longest stone diameter being ≤2cm.
- Scheduled to undergo fURS lithotripsy.
- No preoperative symptoms of infection such as chills and fever, and the most recent preoperative urine culture is negative.
- No immunosuppressive status and no urinary flow obstruction caused by anatomical abnormalities.
You likely can't join if
- Pregnant or lactating women.
- Allergy to the investigational drug(s).
- Participation in other clinical trials within 30 days.
- Presence of other active infection foci requiring antimicrobial treatment.
- Concomitant severe systemic diseases, such as cardiac or pulmonary disease, malignant tumors, and immunodeficiency states.
- Congenital malformations of the urinary tract.
See the full eligibility criteria
- Age 18-75 years.
- Diagnosed by CT with renal and/or upper ureteral stones, with the longest stone diameter being ≤2cm.
- Scheduled to undergo fURS lithotripsy.
- No preoperative symptoms of infection such as chills and fever, and the most recent preoperative urine culture is negative.
- No immunosuppressive status and no urinary flow obstruction caused by anatomical abnormalities.
- No use of long-acting antimicrobial agents within 7 days prior to surgery, and no use of intermediate or short-acting antimicrobial agents within 72 hours prior to surgery.
- Has signed and dated an informed consent form, indicating that the patient or their legal representative has been fully informed about the study-related information and has agreed to participate.
- Pregnant or lactating women.
- Allergy to the investigational drug(s).
- Participation in other clinical trials within 30 days.
- Presence of other active infection foci requiring antimicrobial treatment.
- Concomitant severe systemic diseases, such as cardiac or pulmonary disease, malignant tumors, and immunodeficiency states.
- Congenital malformations of the urinary tract.
- History of kidney transplantation or urinary diversion surgery.
- Unable to provide samples or complete follow-up according to the study protocol.
- Unable to provide informed consent.
- Inability to achieve complete placement of the flexible negative-pressure suction sheath.
- Any other conditions that the investigator deems unsuitable for participation in this study.
- History of diabetes mellitus, immunocompromised.
- Renal insufficiency, neurogenic bladder.
- Recent preoperative history of stone-related fever.
- Long-term indwelling urinary drainage tube.
- Urine white blood cells \>5/HPF (High Power Field) or positive for urine nitrites.
- Large stone burden (e.g., staghorn calculus) or moderate to severe hydronephrosis.
- Imaging findings showing turbid urine in the renal pelvis where pyonephrosis or infectious stones cannot be excluded.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.